FRIEDMAN: We have the luxury of having time for conversation with 4
of the leading experts in the country in 2 different areas, digital
pathology and integrated diagnostics. I am going to start with a
question to both Gene Cartwright and David Okrongly. This question
pertains to a program that has been launched by Siemens and GE. GE calls
it "Early Health Model" and Siemens calls it "Early
Detection and Treatment." I have been fascinated by this concept as
I think it represents a totally new paradigm in the health care process.
I do not want to put too fine a point on this, but early health model
can be defined as preclinical, presymptomatic diagnosis. If a patient is
diagnosed in a preclinical, presymptomatic state, this essentially
brings the diagnostic enterprise to the center stage. We are all used to
the current model where the physician takes a history from the patient
and asks, "What is bothering you?" With the current disease
model, if the patient says "nothing," the physician says,
"I will see you next year," or perhaps some subsequent time.
With the early health model, it is the diagnosticians who are going to
essentially pin a diagnosis on the patient in a presymptomatic state.
There are a lot of participants in the current health care delivery
process who will be agitated and perhaps disturbed by this new approach.
Payers will be bothered for sure and probably Big Pharma, because all of
the clinical trials have been based on treatment of symptomatic
patients. I would like to ask Gene and David to share with us their
perceptions of this early health model, early detection and treatment.
How was this idea hatched and what will be the future implications of
this new paradigm for the pathologist and the lab medicine specialist?

CARTWRIGHT: I will try to answer that in a relatively simple way.
The largest overview at GE for early health was mentioned earlier in the
meeting: taking about 10% of the money that is now spent on therapy and
moving that to diagnostics. If we do that, we believe that we can
significantly lower the total cost of health care. From a diagnostic
standpoint and from a pathology standpoint we see that there will be
great things in our future. I think also at the same time that it
accomplishes a reduction in overall health care costs.

OKRONGLY: I fully agree, Gene, that we have got to focus on how to
move money out of silos and be able to find a way to bring more value to
diagnostics. That is going to be key in implementing an early detection
strategy. We are going to have to start focusing as much on health
economics as we do on the technology and the development of our clinical
plans for these new tests. In fact, reimbursement is going to also play
a big role here, because we've obviously got to be able to get a
return on the investment for those clinical trials and those health
economic studies. The current practices right now within CMS, which are
basically cross walking a new diagnostic test from an existing
diagnostic test from the 1980s, make it difficult to really think about
how new molecular diagnostic tests are going to be reimbursed. Advamed
is working very diligently now. There is both a House and a Senate
version of a bill to create a demonstration program for a more logical,
transparent process for setting reimbursements for these new diagnostics
tests. Part of that would be health economics that would help to drive
changes of behavior and how we fund these things, and also to make it a
little bit easier for a diagnostic company to know exactly what it is
going to get in terms of a return out of a significant investment in new
biomarkers.

FRIEDMAN: Moving money out of silos sounds like a wonderful idea.
David just said there are political ramifications to this approach. Does
the promotion of the idea go beyond the politics? I know many of the GE
press releases that refer to the early health model suggest that the
early health model may reduce costs. Intuitively, I believe that is a
correct assumption. But can we put some numbers behind this idea or do
we have to wait until it is more of a reality and we are deeper into the
early health model to better understand the possible cost savings?

CARTWRIGHT: I do not think we have numbers that we have a lot of
confidence in quoting, but I would say that I would agree with David
that there will be a lot more emphasis on health care economics in order
to get to those numbers. I think Mara Aspinall showed a couple of
numbers where it typically was the savings on the drug costs and not
only on a total-per-patient basis, but on the number of patients who
were successfully treated. There's a lot of work to get to those
numbers and to answer your question appropriately. That is where the
health care economics work has got to be done.

FRIEDMAN: I need to push back on this idea because a previous
speaker showed that the yearly costs of some of these new biotech drugs
can be astronomical. Is it correct to say that pathology and laboratory
medicine will be competing with Big Pharma for resources? We are trying
to drive down the cost of diagnosis but they are trying to maximize
their revenue to quickly cover their development costs of these new
biotech drugs. Is there not, then, a tension in terms of driving down
the costs with the early health model?

CARTWRIGHT: To a degree there is, but I would say that if you look
at the Pharma model and from a Pharma standpoint, I would not be
surprised if the major push for change comes from their finance guy,
meaning that he will be the one to stand up and say, "This model is
not working; this blockbuster model is not working." We need to hit
some singles and we need much higher likelihood of success and those 2
things are also accomplished with biomarkers, so they are not
necessarily competing.

OKRONGLY: I agree. We saw the chart quoting 50% of new drugs
failing at phase III. To kill a drug at a phase III level is a disaster
from a financial perspective for a pharmaceutical company. It is going
to be more and more imperative to develop the right selection model for
patients along the way and that is going to be done with a combination
of in vitro and in vivo diagnostic technologies.

FRIEDMAN: So David and Gene, are pathology and pathologists ready
for the early health model? Are they ready to step up to the plate and
take on this added burden of not only making diagnoses but also
developing therapeutic recommendations? And if not, what do we need to
do to get them and other laboratory professionals to this spot?

CARTWRIGHT: Our job is to prove to our customers, the pathology
base, that we have a solution that does make sense. A lot of work has to
be done on our part and it's a challenge. Physician education is a
challenge. It is probably a challenge for the CAP pathology community;
it is certainly a challenge from a corporate standpoint. We must come up
with new effective ways to educate people about new ideas so that they
can learn a lot more about them within their busy days and without
necessarily making sales calls.

OKRONGLY: I think we are talking about a 5-to 10-year process here.
This is not going to be an overnight phenomenon and I think there will
be enough success stories along the way that will give the pathology
practice time to adopt and change. But I think it starts with a vision
for the future and then starting to take steps along the way to enable
your practice to be ready for that future.

FRIEDMAN: Five to 10 years and this conference is a good start in
that journey. Picking up on this same physician education theme, I want
to turn to the topic of digital pathology with Dirk Soenksen and Mark
Newburger. Dirk mentioned this very briefly, but I want to commend him
in the sense that in the digital pathology world, Dirk and Mark, not
only have you had to create a new product category but you have also
been required to educate potential clients, the pathologists, who will
derive the most benefit from this technology. I saw this same theme
represented in their presentation--they have developed tech nology but
are also educating at the same time. I am also interested in the fact
that Aperio has created its own conference, the Visions conference. I
cannot think of any other precedents where a company offers a very
sophisticated yearly conference. I think this engagement in physician
education is to their credit. I would like to know how Dirk and Mark
react to this comment. Did you get into this business knowing that you
would have to not only create the product but also create the market as
well? Perhaps Dirk first and then Mark.

SOENKSEN: I have been involved in getting new technologies launched
and one of the key ways in which you start is to create awareness of the
possibility. For those of you who may have gotten to know Aperio 7 to 8
years ago, we had a lot of vision about where this field would go. We
would go around the country and essentially talk about the vision and
then as we were able to add some reality into it, the mix of vision
versus reality has changed to where it is today. We have mostly reality.
We are a leader in a very exciting market. Our biggest challenge 2 years
ago was lack of awareness and so we made a deliberate effort to raise
the level of awareness. Awareness just meant you had to be aware of
digital pathology. It did not have to be from Aperio or any other
vendor; we just wanted to create awareness in the space. I would say
today we are at a point where a large number of people are aware of
digital pathology. A lot of people still have fear, a lot of people do
not see the value, and there certainly is not full acceptance yet along
the lines of what we heard earlier today. Today, I think the next step
is all around proof sources. This is all around educating again because
people are generally aware ... some people have a good impression of the
technology, others say it is not for me, but we now need to fill in the
blank with real proof sources, with data, clinical studies that have
been done, pilot studies that are conducted and then say, here are
exactly the results we got. Here is where it was before, here is what it
was after, to provide something more tangible to people who are not
aware of the technology. This is all part of an educational campaign.
Our view of our Visions is that, 5 years from now, Visions may not be an
Aperio-sponsored conference. It could be turned over to another group
and it could turn into its own industry conference. There is no real
excitement I have for spending hundreds of thousands of dollars on
Visions every year, but we think in general that we have to grow the
market for the businesses to become successful. At some point it will
get turned over to a steering committee and it will take on its own
character and we would love that. At this point that is not the case so
we will continue to hold the reins. But if you fast forward, that is how
Visions is going to be. It is going to be a digital pathology conference
and the fact that Aperio got it off the ground may be something that not
many people even remember.

NEWBURGER: I've been promoting digital pathology in one form
or another for 2 decades now and it is refreshing that people are
starting to be focused on what it can do within the laboratory
environment. I think it is important, however, that while we have a lot
of technologies to bring into play, we need to be focused on the
strategy of the business of pathology and the diagnostic operations of
pathology and what the key is to making all that work. There are a lot
of tools to help with diagnostics, but it is the pathologist who brings
it altogether and makes the work flow go. What we are focused on is
understanding the business that you are in and what your strategic needs
are, and then helping you develop a strategic plan to get that forward
utilizing whichever technologies make sense both today and in the long
term. I agree with the rest of the panel that in 5 to 10 years it will
be a whole different world, but we need to get to that and we can talk a
lot about the technologies and need to talk about the technologies, but
we also need to know how we get from here to there and not just imagine
us popping into there. We have to have a road to get there.

FRIEDMAN: I am going to ask one more question and then open the
floor to questions. Dirk, in your presentation I was reminded of
"the dog that did not bark" from the Sherlock Holmes's
stories in the sense that you made hardly any reference to whole slide
imaging. It seems to me that your approach in this area was a more
go-slow one when you talked about mature applications and yet, Gene, in
your press releases for Omnyx, you discussed a 2-to 3-year horizon for
the evolution of the mature technology. I now turn to Dirk and Gene to
discuss the future of whole slide imaging, to comment on when you think
it will be a practical reality, and how we ramp up into the broader
application of the evolution of the digital pathology department.

CARTWRIGHT: I am speaking a little bit for GE as well as Omnyx. It
is our job, the size company we are, to address big problems. That is
our focus. I do not think there is a big disagreement between Dirk and
myself on this, but we are squarely focused on how to make digital
pathology make a solution for the clinical environment and make it work
in hospital-based systems and reference laboratories in a very positive
way for everyone. I am certain that we will also have an ability to sell
into the research environment as well, but we are focusing on what we
consider arguably the hardest problem, the biggest problem, and feel
that is the kind of problem we should be focused on.

SOENKSEN: The question really highlights how we started the
morning, which was to talk about the innovator's dilemma, and I
think what Gene just basically said is that for a company like GE to
move the needle, they would have to focus on the big problem that is
going to give them the big return. They probably could not think about
applications for tumor boards and secondary consults and frozen sections
and quality assurance because that is where we are. I think it is an
interesting question about what the strategy is, whether a niche
adoption strategy will lead you long term to be successful. In other
words, will Aperio by doing the niche adoption be the long-term winner
or will somebody like a GE that focuses on the long-term problem turn
out to be first across the finish line. I think that is very interesting
and I look forward to seeing how that develops in the market.

With respect to the question about whole slide imaging, when we
started this company back in my garage in 1999, we had to build a
scanner. It was clear that the hours per slide to scan a slide in that
day were not practical. It had to be minutes a slide, so we had to come
up with a way to rapidly digitize a slide. The second we did that, we
focused on the development of software and the back end because at the
end of the day nobody wakes up in the morning saying, "I want to
scan a slide in 30 seconds." That is just not something that you
wake up and say I need to do. What you wake up to do is you say, "I
want to be more efficient. I do not want to have to spend 3 hours doing
this. I want this to be done in 1 hour," which is what Gene was
talking about: the integration into the workflow and really solving
problems. I would say the scanner is going to be the first part of this
that is going to become a commodity. It will be the first part where you
want to have scanners from a variety of vendors and you want them to be
interoperable, so we're making good progress on DICOM standards and
I would expect in the next year or two that you will be able to buy
scanners that should interoperate. Just like in radiology where you kind
of have the modality, which is the hardware, you have the PACS, which is
the software, and you have the CAD, which is the analytics; you are
seeing the same thing in pathology, so you have the modality in
pathology, which are the scanners, then you have the software, which is
the PACS and the image management, and then you have the analytics and
certainly there is more opportunity for analytics in pathology than
there is in radiology. I think that is what is exciting certainly from
Aperio's perspective.

FRIEDMAN: I have found myself somewhat embarrassed by the asymmetry
between the field of radiology and pathology regarding the adoption of
digital technology, with radiology all digital and with us still working
almost exclusively with our glass slides. I think is possible for us to
accelerate our adoption of digital technology such that we can achieve
almost equal parity with our colleagues in radiology.

Let us now open to the audience for any questions.

JARED SCHWARTZ: I have a question that relates to thinking about
the digitalizing of pathology slides from experiences in radiology. We
have obviously discussed this significantly in our department and I have
talked with pathologists. We have about 50 radiologists. We have gotten
to see them during the last 20 years go from film to digitized images.
You go into their darkroom and there are just zillions of images all
over the place and a lot of them are whining to us, "There are so
many images." In the old days we only had a few things we had to
look at and now we have the capability of looking at a limitless number
of images. The pathologists are saying, "What is this going to mean
for us?" Right now we make a decision to put on a slide 1 section,
3 sections, 10 sections; but what is going to happen when it is
digitized and what about the legal liability issues, and so forth? Right
now we talk about cutting through the block or cutting in deeper. You
are always anxious; oh, my God, if we cut 3 more microns we might find
the cancer or whatever. What are your thoughts about how that is going
to affect productivity and efficiency and are any lessons to be learned
from radiology for pathology?

CARTWRIGHT: For our venture, Omnyx, we have a partner. The
University of Pittsburgh Medical Center (UPMC) and the pathologists at
UPMC are a 50% partner in our company. In effect, we will be designing
it with pathologists every step of the way, not to say that it will
easy, but certainly that was one of the main reasons we decided to
partner with them. Second, something that Dirk mentioned, his fourth
quadrant. Really what you are talking about is how to make that viewing
experience both richer and nonconfusing and those sound like they are at
opposite ends of the spectrum. Richer sounds like a lot more stuff;
nonconfusing is just the opposite. It is not a simple task to put those
together. Hopefully we will learn from what mistakes have been made in
radiology.

SCHWARTZ: What we have observed in radiology is that during the
last few years to continue to sort of drive the revenue curve, the
manufacturers of these devices have made them more sophisticated. So
instead of getting a CT or an MRI that has 16 slices, now you have 32
and 64 and, of course, now you can have a radiologist looking at all the
different slices and looking for something abnormal so then the need for
a computer to highlight where you should look is much higher. I think
radiology is just giving more data and it is probably overwhelming the
radiologists and there are not tools available to allow them to manage
this. In concurring with what Gene said, the vision here is to have a
pathologist's cockpit that provides all the information you need at
your fingertips. People always ask me, "Do you really think it is
going to be faster to read out a slide on a monitor than on a
microscope?" You might be surprised at the answer, but I do not
think that is the case. I would say if you give a pathologist a glass
slide and you give him a microscope and then you say, "Read it
under the microscope versus reading that digital slide on a
monitor," he is going to be more efficient reading that glass slide
under a microscope. You know what? That does not defeat the purpose of
digital pathology because in digital pathology the goal is not to read 1
slide; the goal is to read out a case and to get a report out. If I say,
"Hey, you know what? I can make it more efficient for you to read
out 4 or 5 slides, maybe to synchronize them in a way that you cannot do
under the microscope. I can bring up a previous case history, I can
integrate flow, and I can integrate cytogenetics and molecular data and
I can put it all on one screen." Now if I ask the question,
"Is digital pathology going to be more efficient than the way you
do it today?" I will take that bet and I think the answer will be
yes, we will have to prove it. One on one, just slide versus slide, you
cannot beat the microscope and you cannot beat the glass slide. But in
an integrated environment where you are trying to do things very quickly
and efficiently and to address the needs of an aging population and the
number of tests, I think digital pathology will address that problem
particularly well.

ROGER SMITH: All the panelists are personal innovators and the
companies are really corporate innovators. They are really trying to do
things and transform pathology practice, but not all the innovation in
the world goes on inside companies or inside your companies even. Can
you give us some sort of insight into corporate strategy for evaluating
innovations that occur elsewhere? How you decide whether to partner or
to try to bring them in-house or to establish some sort of relationship.
Is it something big enough to move the needle, which in the case of GE
takes a lot more than some other companies?

SOENKSEN: There are 2 ways to really tackle that problem in terms
of partnering with folks who are not in companies. In the early days we
got a ton of feedback from pathologists. We would listen to them and
many of the pathologists in this audience here were some of the folks
who gave us feedback early on about what worked and what did not work.
Fundamentally, in terms of scalability, if you think about the sorts of
real value that could be added by academic institutions, you really want
to have academic institutions have the freedom to take the bits and
pieces you have built and to add on top of that. So I think this goes
back to the need for having open standards and having an open system
that others can attach value to. In the case of Aperio we have a large
number of investigators who are using our development tools to develop
their own algorithms, to develop their own user interfaces, to integrate
with their own LIS systems, with their own EMR systems, so we have built
something and we have documented all the interfaces and so many of our
customers are really excited that they have tremendous flexibility in
terms of how to leverage that, so that was how we planned to address
that kind of question.

OKRONGLY: From a diagnostic perspective on the in vitro side, a
really key factor for us is being able to access not only outstanding
investigators but also biobanks, plasma, serum, and tissue that are
going to be associated with long-term outcomes that will allow us to do
a lot of the testing in a retrospective mode, at least in the finding
mode where we're trying to develop an algorithm and be able to sort
out from that algorithm what is the right way to differentiate the
patient groups we are looking at. In our long-term strategy we come up
with the areas that are of greatest interest and, no surprise, it is
things like cardiovascular disease, neurology, infectious diseases, and
cancer. That is how we look for the partnerships that are going to drive
our programs: either things that start out in the universities that are
tested in their own biobanks that we bring internally or the other way
around. We have got an idea and we want to go and do some work. We will
partner around the availability. The validation burden for these tests
is really, really large. You have to have solid data to be able to
convince pathologists or oncologists that there is a different way to
start looking at a disease.

CARTWRIGHT: I think I would separate discovery from development.
What companies are good at is more development. What the academic
community, in my experience anyway, is better at is discovery and so I
always try to remind our own people of that. Even if you look at as
large a company as GE or Siemens is and you look at the amount of money
that we spend on discovery and add it up, multiply it by I do not know
what number, it is still a tiny number to spend on discovery compared to
government funding, venture capital funding, academia, and pharma. That
is where the money is on discovery. What we need is very smart people
internally who really focus on what is going on and are fully
knowledgeable of what is going on in discovery in the market and then
when they see something good to bring it in and develop it.

NEWBURGER: From our perspective, we are focused just on PACS and
that component in software. We focus primarily on development, not on
discovery at all. All of our discovery happens by the relationships that
we build with the academic institutions, people mostly out in this
audience or some people that were not able to attend and then we get
into a licensing scheme with the capabilities that we add onto or we
build relationships with the devices that we are hooking into like all
the guys on the panel with me, so it depends also on corporate strategy
as to how you approach it. A group like GE, which has discovery, but
also a lot of development, or a group like Apollo, which is primarily
about development.

JAFFE: It strikes me from a National Institutes of Health
standpoint that one of the things that is not going to move the field
forward very rapidly is the issue of simply transferring images and
making them do the same thing by subjective analysis. The cutting edge
for us in radiology really is the issue of computer-aided diagnostics
because that is going to solve some of the problems of how do you deal
with viewing a whole block. The key element to that from what we
consider our major investment is open databases of collections that are
annotated. If the community here can do anything at all, it is to move
beyond ... once they get their things digitized ... what they have to do
is make their contribution of ontologies and markup so that then the
imaging processing groups can take the next step. You must have massive
databases to do this because you need to look at the statistical
properties of the spectrum of disease. It is not going to be possible to
do it with a few other investigators. It is got to be the whole society
that does it. We are doing that a little bit with radiology, I think,
rather successfully on a number of things because it is opening up new
windows particularly on issues of quantification and I see that as being
a very important investment that everyone in the community can make and
only the community can make that, once you get beyond the issue of pure
digitization and common resources for sharing images are possible.
Perhaps someone may comment on the issue of where they think
computer-aided diagnostics can go, but we see that as the frontier.

SOENKSEN: I completely agree with what you said, but a challenge
from the corporate standpoint is how fast to run and we want to be
running fast, but always at the direction of the pathologist and we do
not want to outrun the pathologist on computer-aided diagnostics. That
is really the challenge that we have. We just want to keep a very open
dialogue so that we do not outrun how fast the pathologists want to run
here.

JAFFE: But this is the point that Allen Kaye makes about inventing
the future. The burden is not on industry; the burden is on the
community because if they are going to go farther than where they have
been, than substituting simply a digital view of what they could have
done on a slide is not going to be enough. In order for them to create
their own future, it should not be the burden of industry. We at the
National Institutes of Health want to have this moved forward. We are
happy to meet on some communications basis with the community here if
they are ready to advance that, but the key issue is not simply
digitization. It is the subjective value add of annotation and
ontologies that go with that.

UNIDENTIFIED: I agree with that. I think that the way that we get
to there both from a partnership between industry and the community is
by the development and finalization of standards, and DICOM is an
important standard. Unfortunately, it is still not done for pathology
yet. It has taken years to get to where we are now. We were all part of
the CAP initial meetings back in the 1990s, but as those standards
become enforced within DICOM the same way for pathology that they have
become in radiology, I think there will be a real opportunity to build
those community repositories for imaging so that computer-aided
diagnostics can get further along. I agree. I think CAD is an important
part, but I think it is also important to realize that the pathology
community for its entire existence (hundreds of years) has been choosing
what they are going to look at and not being overwhelmed by the amount
of information. I do not think that moving to digital pathology will
slow that down. I think that it will actually enhance their ability to
look at more because it will free up from a commercial basis
unreimbursable time to be used for reimbursable time, which will drive
what you are talking about.

UNIDENTIFIED: I'm a second-year resident in pathology and
since the conference is about the future of pathology I have a question
from a future pathologist. I see the corporate world entering the
practice of pathology. We will see if it is for good or for bad. But
what is your message, your take-home message for us, the residents,
regarding the changes that we should expect in the practice of
pathologists during the next 5 to 10 years? Do you want us to acquire
toolkits that will help us adapt to what you are bringing in the future
or do you want us to look forward to changes from your side and with us
to adapt? What is your message for us, the residents?

SOENKSEN: The reason we have conferences like this and the reason
that Visions exists is to maximize the feedback that we get from the
pathologist. I think the path of how we get there is not entirely clear
to any of us, but the worst path to take would be to say, we will design
it and then we will show it to you when we're ready; that would be
kind of silly. I think in many cases what we would love from the
pathology community in general is the maximum amount of feedback about
the way they see the value, some suggestions about where the pain is the
biggest. We do market research just to get those kind of answers, so if
people were more forthcoming about suggestions, that would be very
helpful to all of industry because largely our goal is to address your
needs and if we fail, it is because we didn't do our homework. I
think it is done in collaboration so I think from the perspective of
being a resident, this is a very, very exciting time and I think the
residents in pathology have an opportunity to really shape what the
tools look like that you are going to be using for the rest of your
careers most likely.

UNIDENTIFIED: My question was prompted by the comment about the
open source and development of algorithms and extracting value from
public databases. This sounds wonderful but the concern from a
commercial perspective is what happens to the discoveries. There are
potentially serious IP ownership issues, which can impede the actual
commercialization because if everyone owns it, no one owns it and it may
be hard to commercialize and actually make it available to the greater
community.

CARTWRIGHT: It is certainly an issue in gene discovery and
gene-associated algorithms for differential diagnosis. I think there are
a few areas that you have got to pick in your portfolio that you say we
are going to work really hard to drive our own IP in that area and then
it is going to be pooled at some point with other intellectual property,
but I think the delivery at the end of the day is going to be how well
you validate it, how well you can implement it, and how well you can
integrate it into existing clinical workflow. The intellectual property
certainly is clearly important and likely you will see every company is
going to focus on a couple of key areas. But at the end of the day there
is a lot more value added than just the test itself. There is going to
be the workflow component and how you get your message out to the
oncologist, to the cardiologist, whomever you are targeting with that
new diagnostic modality that will really bring value.

SOENKSEN: (response to question from unidentified individual) If I
understand your question, we are talking about searching images and the
application of algorithms. One of the ways we think about that is if you
want to develop your own algorithms and you have your own digital slide
repositories, you have the opportunity to create tremendous IP for
yourself. I think then as a community the pathologists can get together
... it is all related to how valuable the data is. Companies like ours
do not have access to a lot of pathology data and it is not our
business, so I think there is tremendous IP that could be generated in
the community if people saw the value of doing that and I think industry
would support that. We would give you the tools and we would help you as
much as we can, but having IP in that area is not something, I do not
want to speak for these guys, but that is not something that is our
business at all.

SCHWARTZ: I want to answer the resident's question. When he
asked it, I saw some squirming up there, and I thought maybe this was a
more appropriate question for one of the pathologists to answer. I think
it is fascinating. Again, this goes back to the issue of human nature.
As I have been going around to all these different medical centers,
university training centers, one of the first questions I ask is,
"Do any of your medical students have microscopes any more?" I
would say more than 90% respond, "No, we do not use microscopes any
more in medical school." All the histology they learn and their
pathology, everything is done using digital images. You say, "How
about your tumor conferences? How is that done?" Again, they may
not be using a specific digital system, but they are using digital
technology for the conferences. The radiologists are observing; the
radiologist is totally digital. I have been accused at a few meetings of
hating microscopes. Actually, I do not hate microscopes; microscopes are
wonderful. Every day when I am home I use my microscope. It is a tool. I
think that what we are seeing now is the medical schools are using a new
tool to show images. We look at images and again it is hard for me to
understand why this is not moving up into the residency training
programs; it is at some places. There definitely are places where it is
current, but in general it is not. I think that the speed at which it
will happen is going to be very fast because for the new group moving up
into the training programs, that is all they are used to; they are
already used to video games and everything else that is digital and the
acceptance is very rapid. I am very optimistic that getting the
customer, as we say, to adopt this will come very fast. I think we saw
it with Smartphones; we saw it with a lot of others in my particular
group. A couple of people get the technology. Everyone else says they
will never have it and then a month later everybody has got a
Blackberry. I think we should be very positive and optimistic about it.
It will take education, but we are going to do it and that is part of
the reason the CAP is here today.

FRIEDMAN: I can't let this panel terminate without having an
information technology (IT) question and a number of speakers and the
panel members have talked about IT. You guys are all about IT. I think a
lot about the issue of the explosion of science and technology in
pathology and in radiology. I am continuously frustrated by what I would
call fairly slow progress in terms of the EMR and using the EMR as the
"sole reporting vehicle" for this explosion of images and
signs in pathology and laboratory medicine. There are some political
implications (I don't even want to get into that), but I just want
to ask all of you for a future scenario in hospitals for information
technology given what we have learned today. What is your vision? How
are we going to report to our customers using images, using the
sophisticated genomics and proteomics now at our disposal and that we
have in our LISs? How do we talk, how do we communicate with them
digitally and electronically? I would like to address those questions to
the entire panel.

CARTWRIGHT: At GE we have a very big effort underway at
Intermountain Healthcare in Utah. We have about 250 engineers out there
working on an electronic medical record just to address the point you
made. Secondly, I think the way I envision this (and this is my personal
opinion) after we get that done, eventually it will evolve to where a
patient comes in, they have their family history, their genetic
information, they will have their image information, they will have
prior stuff and so forth, and that will just be one very big pattern of
data. Just image it is like a little universe of data. Then that pattern
will be compared to 10 million other patterns that are stored on a
computer. You will display other patterns of that 10 million that are
very similar to the pattern you generated of your 1000, 10 000 or so
data points, and then each of those 10 million cases will have an
outcome associated with it and that will be your confidence level for
your diagnosis.

FRIEDMAN: Gene, where does this data reside? Right now the health
systems view the data as proprietary. There is an emergence of PHRs.
There is a kind of fragmentation of this data and it is hard for me to
understand. There are ID problems; I do not even want to get into that.
Where does the impetus come for the integration of these heterogeneous
islands of data?

CARTWRIGHT: I do not think I am capable of answering that question
to be honest with you. It is a big question, a good question, but I do
not have the background to deal with it.

OKRONGLY: I think an interesting development is the announcement of
Google to be looking at ways of putting together medical information. I
think that could be a really significant driver of change. I see this in
the future as a very Web-enabled approach to how we get at health care
records. When companies like Google and Microsoft start to show an
interest in this area, we could be in for some really interesting
developments in the next few years.

SOENKSEN: Why wouldn't we get to the state where you have your
electronic medical record on your iPod? It is proprietary, nobody else
can look at it, but you can have it yourself. So why wouldn't you
be in a position where you have an iPod with a terabyte of data and you
carry it around and wherever you go, it gets plugged in and whatever is
needed gets uploaded and you own it?

FRIEDMAN: The problem has always been updating that information and
with the health systems, there is no reimbursement for them to keep that
fresh. The reimbursement is for their own purposes.

NEWBURGER: One of the things that the information technologies that
we are all working on bring about is a kind of transparency from the
various specialty departments to the patient. While we are not there
yet, I agree with everybody else that the Google and Microsoft focus on
the health care record is an important indicator and not necessarily the
answer, but an important indicator that information technology is going
to help us get to division of this transparency. It has been done in
several other different industries for the sharing of proprietary data.
Finance comes to mind. There are several different methodologies that
could work. It is just which one can we get to politically,
technologically, and cost-effectively. As long as we all keep working on
our piece of it with long-term possible visions we can get there.

FRIEDMAN: One other factor is that we are not totally cognizant of
is Health 2.0 and the empowered health care consumer who will not be
passive and not tolerate this sort of paternalistic attitude toward
health care. That is another thing in the mix. One more question then we
will terminate.

UNIDENTIFIED: This isn't a question but I feel like Jared, I
have a responsibility to speak up and answer the young resident's
question. I am one of the pathologists from UPMC who is working with
Omnyx to build this solution, but I want to make sure that we get the
message across that this tool that we help build is specifically for us
and specifically for the pathologists out in the audience. This is for
your workflow. I totally feel your pain. We have been looking for this
sort of opportunity for a long time where we can have kind of a creative
hand, a guiding hand, in how to design the software and how to design
the hardware to fit into our workflow. We have about 20 hospitals and
120 anatomic pathologists who pump out lots and lots of glass every day.
So my personal goal and the goal of all the other pathologists who are
working on this project is to make our workflow better with digital
glass not just for one bench, but for all the benches. We feel happy
enough that Omnyx has written good software and good hardware. When we
feel okay that we can deploy it here, then we can put our name on it and
others will be able to use it to enhance their workflow. You can think
of it as a super tool, a super microscope, something to give you turbo
boost in your practice rather than being told this is another corporate
piece of software that you guys have to use. That is not the way we want
this project to come out. You will move from your microscope to your new
sign-out station and you will just feel right at home, so we really have
been lucky and blessed that the new company has given us a little bit of
creative control over the design process and like I said, it is
something that we have been looking for. So I wanted to answer that
question in that, do not ask yourself, should we be afraid of this? Tell
yourself that this is something that you need to get a hold of and that
you need to not prepare for, but look forward to in the next few years.

UNIDENTIFIED: I think the technology already exists. If you are
creative, you can integrate already in terms of digital practice. I do a
lot of it myself. The big question is, not so much the vision of what we
can do, but how do you get paid to do it? That is the big challenge with
the digital integration. If you cannot get on the insurance panels what
does it matter if you can do it, if you cannot get paid to do it because
then you cannot pay you guys for the technology to do it.

SOENKSEN: I agree. We will pay for it. We are all in business so
the onus is really on us as vendors to demonstrate the value of this.
Reimbursement may play into this. There are CPT codes in place for
reading slides. They do not have to be glass for you to use that CPT
code. If there is value in adopting the technology for other
applications, it has to be demonstrable. If we are saving you 10 hours a
week, what is that worth? If saving you 10 hours a week to do something
saves you enough money to be able to buy one of these types of systems,
that is great and if not, then we have got to make it 20 or 30 or 40
hours. I think the value comes out of the productivity and that is how
we view it. Getting CPT codes and other things is certainly on the
horizon, but it is a long slog. We have embarked on that, but I think in
the short term it just has to be driven out of the productivity and
efficiency benefits that you get and there are some. The reason that
there was such a long list of niche applications I talked about is
because each of them has a slightly different value proposition for a
specific user.

Accepted October 1, 2008.

Presented at the College of American Pathologists Futurescape of
Pathology Conference, Rosemont, Illinois, June 7-8, 2008.